Cholelithiasis Clinical Trial
Official title:
Effectiveness of Ursodeoxycholic Acid Use in the Prevention of Gallstone Formation After Sleeve Gastrectomy: A Prospective Randomized Multicenter Placebo-Controlled Trial
This is a randomized double-blind placebo-controlled trial with a total of 100 patients who are free of gallstones at baseline. The study involves taking an oral drug (Ursodeoxycholic Acid 250mg) or a placebo twice daily for a period of six months and undergoing a total of three abdominal ultrasounds (at 6 months, at 12 months, and at 18 months) to check for gallstones.
A significant proportion of patients are known to develop gallstones during the phase of
rapid weight loss after bariatric surgery. A small percentage of these patients develop
symptoms such as abdominal pain, nausea, vomiting, and occasionally more serious symptoms
relating to gallbladder disease. Those patients may require surgery for the removal of their
gallbladder even though the risks of gallbladder surgery are increased in this patient group.
The investigators would like to provide patients who have undergone Laparoscopic Sleeve
Gastrectomy a drug that will reduce the risk of developing gallstones during the phase of
rapid weight loss after surgery. The drug, Ursodeoxycholic acid, is FDA approved for the
reduction in gallstone formation in obese patients undergoing rapid weight loss but has never
been proven effective, by randomized controlled studies, in the subgroup of obese patients
undergoing Laparoscopic Sleeve Gastrectomy. If proven so, the investigators intend to
influence the current practice such that all patients are offered Ursodeoxycholic Acid for
the reduction of gallstone formation and their complications following Laparoscopic Sleeve
Gastrectomy.
In this randomized double-blind placebo-controlled trial, the subjects will be approached by
the principal investigator in the clinic with information about taking part in this study,
after the decision is made to undergo Laparoscopic Sleeve Gastrectomy for weight loss. The
surgeon will answer any questions then and thereafter. The investigators will clarify that
participation is voluntary and will not alter routine care whether the patient participates
or not. The study involves taking an oral drug (Ursodeoxycholic Acid 250mg) twice daily for a
period of six months and undergoing a total of three abdominal ultrasounds (at 6 months, at
12 months, and at 18 months) to check for gallstones. Patients should be gallstone free on an
initial ultrasound to satisfy the study inclusion criteria. Ultrasound testing is radiation
free and does not pose any additional risk to the subjects.
A total of 100 patients need to be recruited. The sample is comparable to current studies and
is sufficient to prove or disprove the hypothesis with low risk of error (ref). The patients
will either receive placebo or the drug under study, the placebo being dispensed from the
pharmacy and having the same color as the ursodeoxycholic acid. The principal investigator
and the radiologists measuring the result will be blinded to whether the subject receives the
drug or placebo.
The study needs to involve human subjects so that the results will be applicable to human
subjects. The risk is small because the drug is FDA approved with 13 years post-marketing
experience for related indications and is known to be well tolerated. All efforts will be
made to protect the privacy and confidentiality of the subjects including protecting their
personal information by removing identifiers from data records and storing the identifying
codes in a separate location, with all study material under password protection or lock and
key at all times.
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